美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D69223050102 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.131990001991021991361992411992671991490.06
219.191998261999011998640.03
单位质量响应值RSD%判断
10410.3010415.010.04数据可信
稳定性考察-加速6月-供试品溶液-12343797批-pH7.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min14606-46062.3182.494.102.322.494.01
25112-51122.5732.57
34929-49292.4802.48
45134-51342.5842.58
54822-48222.4272.43
65047-50472.5402.54
10min18780-87804.4184.775.074.444.805.10
29891-98914.9785.01
39637-96374.8504.88
410045-100455.0555.08
59090-90904.5754.60
69469-94694.7654.79
15min111344-113445.7096.083.275.786.163.30
212317-123176.1986.28
312119-121196.0996.18
412494-124946.2886.37
512090-120906.0846.16
612169-121696.1246.21
20min114349-143497.2217.814.247.367.964.23
215936-159368.0208.17
316109-161098.1078.26
415969-159698.0368.19
515284-152847.6927.84
615416-154167.7587.91
30min124680-2468012.42013.062.7012.6413.292.72
226351-2635113.26113.50
326540-2654013.35613.60
426464-2646413.31813.56
525942-2594213.05513.29
625704-2570412.93513.17
45min134578-3457817.40117.501.8617.7617.881.82
234381-3438117.30217.69
335947-3594718.09018.48
434070-3407017.14617.54
534857-3485717.54217.92
634844-3484417.53517.91
60min144767-4476722.52923.262.4023.0823.842.39
246402-4640223.35223.93
347165-4716523.73624.32
447769-4776924.04024.62
545549-4554922.92223.49
645712-4571223.00423.58
极限150708-5070825.51926.632.0826.3227.472.07
253128-5312826.73627.58
353268-5326826.80727.66
453556-5355626.95227.80
553359-5335926.85327.68
653535-5353526.94127.77
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D69223050102 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.131993151993381992351995501995411993960.08
219.191996071995001995540.04
单位质量响应值RSD%判断
10423.2110398.850.17数据可信
稳定性考察-加速6月-供试品溶液-12343797批-pH7.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min14572-45722.3012.466.192.302.466.20
24623-46232.3272.33
34767-47672.3992.40
45344-53442.6902.69
54874-48742.4532.45
65137-51372.5862.59
10min18892-88924.4764.655.334.504.675.34
28601-86014.3294.35
39320-93204.6914.72
410059-100595.0635.09
59254-92544.6584.69
69260-92604.6614.69
15min111734-117345.9066.104.285.986.184.31
211297-112975.6865.76
312118-121186.0996.18
412676-126766.3806.47
512492-124926.2886.37
612376-123766.2296.31
20min115149-151497.6257.753.117.777.903.13
214706-147067.4027.54
315685-156857.8958.04
416092-160928.0998.26
515541-155417.8227.97
615257-152577.6797.83
30min125563-2556312.86612.951.9413.0913.181.96
225214-2521412.69112.91
325734-2573412.95313.19
426676-2667613.42713.67
525677-2567712.92413.16
625504-2550412.83713.07
45min133993-3399317.11017.832.5017.4818.212.49
235086-3508617.66018.02
335456-3545617.84618.22
436591-3659118.41718.81
536043-3604318.14118.52
635425-3542517.83018.21
60min146178-4617823.24323.331.0923.8023.901.12
245807-4580723.05623.61
346826-4682623.56924.15
446782-4678223.54724.15
546765-4676523.53824.12
645750-4575023.02723.60
极限151950-5195026.14826.811.6926.9627.641.69
252821-5282126.58627.40
353560-5356026.95827.80
453498-5349826.92727.79
554658-5465827.51128.35
653102-5310226.72827.56
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